201 KAR 2:076. Parenteral pharmaceutical compounding.
RELATES TO: KRS 315.020
STATUTORY AUTHORITY: KRS 315.020(1), (2), 315.065(1), (2), 315.191(1)
NECESSITY, FUNCTION, AND CONFORMITY: The Kentucky Board of Pharmacy is responsible to insure minimum standards of practice of parenteral compounding by pharmacies. The board is also responsible to insure the safety of all products provided to the citizens of the Commonwealth.
Section 1. A policy and procedure manual for parenteral pharmaceutical compounding shall be available at a pharmacy for inspection purposes. The manual shall include policies and procedures for:
(1) Oncology drugs;
(2) Disposal of unused supplies and medications;
(3) Drug destruction and return;
(4) Drug dispensing;
(5) Drug labeling;
(7) Duties and qualifications for staff;
(9) Handling of hazardous wastes;
(10) Investigation drug protocol;
(13) Reference material;
(16) Transportation; and
(17) Quality assurance, as relates to:
(a) Recall procedures;
(b) Storage and dating;
(c) Educational procedures for staff and patient;
(d) Sterile procedures, to include routine maintenance and hood certification; and, if necessary,
(e) Sterile testing of end products, operator procedures, and environment.
The manual shall be reviewed and revised on an annual basis.
Section 2. The following physical requirements are in addition to other requirements set forth in KRS 217.055 and 315:020:
(1) The licensed pharmacy shall have a designated area for preparing compounded parenteral pharmaceuticals. This area shall be designed to withstand routine disinfecting procedures and shall be kept free of particulate generators, e.g., corrugated cardboard containers. This area shall be designed to avoid unnecessary traffic and airflow disturbances. It shall be used only for the preparation of sterile products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.
(2) The minimum equipment shall be:
(a) Laminar airflow hood or Class 100 clean room;
(b) Sink with hot and cold running water which is convenient to the compounding area;
(c) Appropriate disposal containers for used needles, syringes, and if applicable, cytotoxic and hazardous wastes from preparation of said agents;
(d) A Class II vertical flow biological safety cabinet, if oncology agents are prepared;
(e) Refrigerator or freezer with a thermometer; and
(f) A temperature controlled delivery container (not required if delivered in the same facility).
(3) The minimum supplies shall be:
(a) Disposable needles, syringes, and other supplies needed for aseptic parenteral compounding;
(b) Disinfectant cleaning solutions;
(c) Hand-washing agent with bactericidal action;
(d) Disposable, lint-free towels or equivalent;
(e) Appropriate filters and filtration equipment;
(f) Oncology drug spill kit; and
(g) Disposable gowns, and sterile disposable gloves.
(4) This area of the pharmacy shall not be accessible to the public and no one shall have access without supervision of the pharmacist.
(5) The pharmacy shall have current reference materials related to sterile products.
Section 3. Each licensed pharmacy shall be managed by a pharmacist licensed to practice pharmacy in the Commonwealth and who is knowledgeable in the specialized functions of preparing and dispensing compounded, sterile pharmaceuticals, including the principles of aseptic technique and quality assurance. The pharmacist in charge shall be responsible for the purchasing, storage, compounding, repackaging, dispensing, and distribution of all drugs and pharmaceuticals. The pharmacist shall also be responsible for the development and continuing review of all policies and procedures, training manuals, and the quality assurance programs, as well as participation in those aspects of the facility's patient care evaluation program relating to pharmaceutical material utilization and effectiveness. The pharmacist in charge may be assisted by additional personnel adequately trained in this area of practice. A pharmacist shall be accessible at all times at each licensed facility to respond to patients' and other health professionals' questions and needs.
Section 4. (1) The pharmacist shall receive a written or verbal prescription or direct copy order from a prescriber before dispensing any compounded, sterile parenteral product. These prescriptions or direct copy orders shall contain the following:
(a) Patient's name;
(b) Patient's address on controlled substances prescriptions or location (room number);
(c) Drug name and strength;
(d) Directions for use;
(f) Authorized prescriber's name;
(g) Prescriber's address and DEA number, if applicable;
(h) Refill instructions, if applicable; and
(i) Dispensing quantity, if applicable.
(2) A pharmacy generated profile shall be maintained separate from the prescription file. The patient profile shall be maintained under the control of the pharmacist in charge for a period of two (2) years following the last dispensing activity. In addition, a medication administration record (MAR) as part of the medical record shall be retained for a period of five (5) years from date of the patient's discharge from the facility, or in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longer. Supplemental records may also be employed as necessary. The patient profile shall contain:
(a) Patient's name;
(b) Sterile product dispensed;
(c) Date dispensed;
(d) Drug content and quantity; and
(e) Patient's directions.
(3) Each sterile pharmaceutical dispensed to patients shall be labeled with the following information:
(a) Name, address, and telephone number of the licensed pharmacy, if product will leave the premises;
(c) Identifying number;
(d) Patient's full name;
(e) Name of each drug, strength, and amount;
(f) Directions for use, including infusion rate;
(g) Required controlled substances transfer warnings, where applicable;
(h) Expiration date;
(i) Identity of dispensing pharmacist;
(j) Storage requirements, when applicable; and
(k) Auxiliary labels, when applicable.
(4) The pharmacist in charge shall maintain access to and submit, as appropriate, such records and reports as are required to insure the patient's health, safety, and welfare. Records shall be readily available, maintained for two (2) years at facility not computerized, but for five (5) years at facility utilizing computerized recordkeeping, and subject to inspection by the Board of Pharmacy or its agents. These shall include the following:
(a) Patient profile;
(b) Purchase records;
(c) Biennial controlled substances inventories;
(d) Policy and procedures manual;
(e) Policies and procedures for cytotoxic wastes, if applicable;
(f) Quality assurance records; and
(g) Such other records and reports as may be required by law and rules and administrative regulations of the Kentucky Board of Pharmacy.
Information regarding individual patients shall be maintained in a manner to assure confidentiality of the patient's records. Release of this information shall be in accordance with federal and state laws.
(5) The pharmacist in charge shall be responsible for the environmental control of all products shipped. Any compounded, sterile pharmaceutical that is frozen or requires refrigeration shall be shipped or delivered to a patient in appropriate temperature controlled delivery containers, if the product leaves the premises.
(6) The pharmacist in charge shall be responsible for assuring that there is a system for the disposal of hazardous waste in a manner that does not endanger the public health.
(7) A quality assurance program documented by the pharmacist shall be available to provide accountability for the manufacturing and distribution of sterile parenteral products.
Section 5. Licensed pharmacies that prepare oncology agents shall meet the following additional requirements in order to insure the protection of the personnel involved:
(1) All oncology agents shall be compounded in a vertical flow, Class II, biological safety cabinet, and other products may be compounded in this cabinet;
(2) Protective apparel shall be worn by personnel compounding oncology drugs, and this shall include disposable gloves and gowns;
(3) Proper aseptic and safety techniques shall be used by personnel compounding oncology agents;
(4) Appropriate disposable procedures for cytotoxic waste shall be developed that comply with applicable state and federal regulations;
(5) Written procedures for handling both major and minor spills of cytotoxic agents shall be developed; and
(6) Prepared doses of oncology drugs shall be dispensed, shipped, or delivered in a manner to minimize the risk of accidental rupture of the primary container and labeled with a distinctive cautionary label as being hazardous.
Section 6. There shall be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. Quality assurance procedures, at a minimum, shall include:
(1) Recall procedures;
(2) Storage and dating;
(3) Educational procedures for staff;
(4) Sterile procedures;
(5) Hood or clean room annual certification by an independent contractor in accordance with federal standard 209B and NSF standard No. 49;
(6) Prefilter cleaning and replacement when appropriate;
(7) Justification of the chosen expiration dates for compounded parenteral products; and
(8) Documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits.
Section 7. Violation of any provision of this administrative regulation shall constitute unethical or unprofessional conduct in accordance with KRS 315.121. (16 Ky.R. 1716; Am. 2152; 2652; eff. 6-10-90.)